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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-12 for * manufactured by *.

Event Text Entries

[19609509] The cap was loose on urine cup. The entire specimen leaked into the bio bag. The patient's rn was notified to recollect.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4735644
• MDR Report Key: 4735644
• Date Received: 2015-02-12
• Date of Report: 2015-02-12
• Date of Event: 2015-01-26
• Report Date: 2015-02-12
• Date Reported to FDA: 2015-02-12
• Date Reported to Mfgr: 2015-04-29
• Date Added to Maude: 2015-04-29
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: CONTAINER, SPECIMINE, NON-STERILE
• Product Code: NNI
• Date Received: 2015-02-12
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2015-02-12